CDC treats first mon­key­pox pa­tient with SIGA's small­pox an­tivi­ral via ex­pand­ed ac­cess

The CDC said Fri­day that one mon­key­pox pa­tient in the US so far has been treat­ed with SIGA Tech­nolo­gies’ tecovir­i­mat, known com­mer­cial­ly as TPOXX, which is an an­tivi­ral agent from the strate­gic na­tion­al stock­pile with an­ti-or­thopoxvirus ac­tiv­i­ty.

The an­tivi­ral is on­ly cur­rent­ly li­censed to treat small­pox, so the FDA and com­pa­ny made it avail­able to CDC un­der an ex­pand­ed ac­cess IND.

CDC al­so said it re­leased small­pox vac­cines — Emer­gent’s ACAM2000 and Bavar­i­an Nordic’s Jyn­neos — to those at high-risk of ex­po­sure to mon­key­pox, ei­ther through con­tact with some­one who has it, or cer­tain in­ter­me­di­ate risk ex­po­sures, such as be­ing with­in ≤6 feet of an un­masked pa­tient for ≥3 hours with­out wear­ing, at a min­i­mum, a sur­gi­cal mask.

But the CDC al­so warned that the post-ex­po­sure pro­phy­lax­is of the vac­cine is not rec­om­mend­ed for those at low or un­cer­tain risk of mon­key­pox (“e.g., health care providers en­ter­ing a pa­tient’s room with­out eye pro­tec­tion”).

News of the first use of treat­ment and vac­cines comes as the CDC says the out­break of mon­key­pox, a zoonot­ic dis­ease from a so-far un­known an­i­mal reser­voir, is now in 9 states. As of May 31, the CDC has iden­ti­fied 17 cas­es in the US, with 16 cas­es di­ag­nosed in per­sons who iden­ti­fy as gay, bi­sex­u­al, or men who have sex with men. Four­teen of the 17 pa­tients al­so re­port­ed in­ter­na­tion­al trav­el in­volv­ing 11 dif­fer­ent coun­tries dur­ing the 21 days pre­ced­ing symp­tom on­set.

“Cur­rent­ly, all pa­tients are clin­i­cal­ly well and be­ing mon­i­tored by health au­thor­i­ties to de­ter­mine the end of iso­la­tion (i.e., af­ter all le­sion scabs have fall­en off, and new, healed skin has formed),” the agency said.

But CDC’s con­tact in­ves­ti­ga­tion is on­go­ing, as among the 13 pa­tients who have iden­ti­fied con­tacts, there are 56 high-, 117 in­ter­me­di­ate-, and 235 low- or un­cer­tain-risk con­tacts.

“Con­tacts are rec­om­mend­ed to be mon­i­tored for signs and symp­toms con­sis­tent with mon­key­pox (e.g., fever, chills, lym­phadenopa­thy, and rash) for 21 days fol­low­ing last ex­po­sure,” the CDC said in a re­port is­sued Fri­day.

While the virus is en­dem­ic in sev­er­al cen­tral and West African coun­tries, the CDC said there are two clades of mon­key­pox virus, West African and Con­go Basin, the lat­ter caus­ing more se­vere ill­ness. Since mon­key­pox reemerged in Nige­ria in 2017, iso­lat­ed cas­es have oc­curred out­side Africa but they have been ei­ther peo­ple re­cent­ly trav­el­ing to Nige­ria or con­tacts of per­sons with trav­el-as­so­ci­at­ed cas­es.

The UK, which is see­ing its own surge of mon­key­pox cas­es too, is plan­ning to com­mis­sion a Phase 2 study to in­ves­ti­gate the ef­fi­ca­cy of tecovi­ra­mat for the man­age­ment of mon­key­pox in a non-hos­pi­tal­ized pop­u­la­tion.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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NICE rec­om­mends Bris­tol My­er­s' heart drug Camzyos in UK

Bristol Myers Squibb’s heart drug Camzyos has been recommended by the National Institute for Health and Care Excellence as the medication inches closer to approval in the UK and Europe.

In final draft guidance released Friday, NICE recommended mavacamten (branded as Camzyos) as an add-on to standard care for symptomatic obstructive hypertrophic cardiomyopathy.

Obstructive HCM is a heart condition that occurs when part of the muscular wall in the heart becomes thicker, which can then reduce blood supply to the rest of the body.

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